COVERED USES:

FDA Approved Indications:

• Locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen (162._).
• Approved as a first-line agent in combination with gemcitabine for advanced, inoperable, or metastatic pancreatic cancer (157._).

Requests for a non-FDA approved (off-label) indication require the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

Must be prescribed by an Oncologist.

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

Tarceva® is approved, subject to benefits, for patients who meet the following:

• Locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen (162._)
• Approved as a first line agent in combination with gemcitabine for advanced, inoperable, or metastatic Pancreatic cancer (157._)

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization and reauthorization will be approved for up to six months.